MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Cough (4457)

Event Date 06/21/2023

Event Type  Injury  

Event Description

I received the first of a series of three injections of euflexxa in my right knee.It was incredibly painful.I received the shot at approximately 10 am.Within an hour i was feeling off.Didn't think anything of it.By 5 pm i was in the emergency room struggling to breathe.Throat was scratchy and began coughing.Red rash all over my chest.Doctors immediately began allergic reaction treatments and advised no more euflexxa.I was better by the time i was discharged.This morning i am heading back to the doctor and once again it is a struggle to breathe.Reason for use: knee injection for osteoarthritis.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 17209427
• MDR Text Key: 318028151
• Report Number: MW5118854
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: FEXOFENADINE; MELOXICAM; NEXPLANON BIRTH CONTROL IMPLANT; TYLENOL
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Hispanic
• Patient Race: White